Schizophrenia Clinical Trial
Official title:
A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of Schizophrenia
| Verified date | March 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. The primary hypotheses are the following: (1) MK-8189 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score (2) MK-8189 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score. With Amendment 4, enrollment was changed to approximately 500 participants with removal of the MK-8189 8 mg treatment arm. Participants enrolled before Amendment 4 that have been assigned to 8 mg MK-8189 will remain on 8 mg MK-8189 per protocol.
| Status | Active, not recruiting |
| Enrollment | 500 |
| Est. completion date | July 15, 2024 |
| Est. primary completion date | July 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: The main inclusion criteria include, but are not limited to the following: - Meet the diagnostic criteria for schizophrenia according to the DSM-5 - Have an illness duration for schizophrenia of at least 1 year - Be confirmed to be experiencing an acute episode of schizophrenia as evidenced by ALL of the following: (a) onset of the current acute episode is =6 weeks before screening (b) current symptoms represent a marked and substantial worsening compared with the participant's usual symptomatic state prior to the current acute episode, and are associated with diminished functional ability (c) in need of increased psychiatric attention to treat worsening acute episode symptoms - Have a CGI-S score of =4 (moderately ill) at screening and baseline - Have an identified responsible person referred to as the "external contact person" who has agreed to provide information about the participant's location if needed during outpatient portion of the study. The site personnel must consider this identified responsible person a reliable contact person, and the contact person must have regular contact with the participant (defined at screening as direct contact no fewer than 3 times per week), and with the expectation that this frequency of contact would continue (either in person or via other contact method), throughout duration of the study, including the follow-up period) Exclusion Criteria: The main exclusion criteria include, but are not limited to the following: - Has a primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment - Meets criteria for moderate to severe substance use disorder within past 6 months prior to screening (excluding those related to caffeine or nicotine) - Has a known history of the following: (a) borderline personality disorder, anti-social personality disorder, or bipolar disorder (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease, or another form of dementia, or any chronic organic disease of the central nervous system (c) intellectual disability of a severity that would impact ability to participate in the study - Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse - Is or was under involuntary commitment for the acute episode, because the participant is considered a danger to themselves or others - Has a history of treatment resistance exhibited by any of the following: (a) no or minimal response to at least 2 periods of treatment lasting 6 weeks or longer, with antipsychotic agents at the maximally tolerated dose. Participants who have responded to antipsychotics only when paired with clozapine are considered treatment-resistant (b) history of electroconvulsive therapy (ECT) treatment for treatment-resistant schizophrenia within the past 6 months (c) past or current use of clozapine as single or adjunctive therapy for schizophrenia within the past 3 months - Is currently participating in or has participated in another clinical study and received an experimental or investigational drug agent within 3 months prior to screening visit of this current study and has participated in no more than 2 studies in the past 2 years |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD ( Site 3002) | Burgas | |
| Bulgaria | State Psychiatric Hospital - Kardzhali ( Site 3005) | Kardzhali | |
| Bulgaria | State Psychiatric Hospital "Sv. Ivan Rilski", Novi Iskar ( Site 3001) | Novi Iskar | Sofia |
| Bulgaria | Mental Health Center - Ruse, EOOD ( Site 3003) | Ruse | |
| Bulgaria | Center for Mental Health Prof. Nikola Shipkovenski Ltd ( Site 3000) | Sofia | |
| Bulgaria | Mental Health Center - Veliko Tarnovo ( Site 3006) | Veliko Tarnovo | |
| Croatia | Klinicki bolnicki centar Rijeka ( Site 4005) | Rijeka | Primorsko-goranska Zupanija |
| Croatia | Klinika za psihijatriju Sveti Ivan ( Site 4003) | Zagreb | Zagrebacka Zupanija |
| Croatia | Klinika za psihijatriju Vrapce ( Site 4000) | Zagreb | Grad Zagreb |
| Croatia | Klinika za psihijatriju Vrapce ( Site 4001) | Zagreb | Grad Zagreb |
| Japan | Soushu Hospital ( Site 2008) | Atsugi | Kanagawa |
| Japan | Chiba University Hospital ( Site 2024) | Chiba | |
| Japan | Inokuchi Noma Hospital ( Site 2030) | Fukuoka | |
| Japan | Kuramitsu Hospital ( Site 2014) | Fukuoka | |
| Japan | Ongata Hospital ( Site 2007) | Hachioji | Tokyo |
| Japan | Tanzawa Hospital ( Site 2037) | Hadano | Kanagawa |
| Japan | Kohnodai Hospital, National Center for Global Health and Medicine ( Site 2005) | Ichikawa | Chiba |
| Japan | National Hospital Organization Hizen Psychiatric Medical Center ( Site 2017) | Kanzaki-gun | Saga |
| Japan | Rainbow and Sea Hospital ( Site 2016) | Karatsu | Saga |
| Japan | Nishigahara Hospital ( Site 2042) | Kita-ku | Tokyo |
| Japan | Wakato Hospital ( Site 2031) | Kitakyushu | Fukuoka |
| Japan | National Center of Neurology and Psychiatry ( Site 2023) | Kodaira | Tokyo |
| Japan | Komoro Kogen Hospital ( Site 2046) | Komoro | Nagano |
| Japan | Yuge Hospital ( Site 2018) | Kumamoto | |
| Japan | National Hospital Organization Ryukyu Hospital ( Site 2019) | Kunigamigun | Okinawa |
| Japan | Amekudai Hospital ( Site 2020) | Naha | Okinawa |
| Japan | Shiranui Hospital ( Site 2043) | Omuta | Fukuoka |
| Japan | Narimasu Kosei Hospital ( Site 2006) | Tokyo | |
| Japan | Seijin Hospital ( Site 2026) | Tokyo | |
| Japan | Seimou Hospital ( Site 2004) | Tomioka | Gunma |
| Japan | Seishinkai Okehazama Hospital Fujita Kokoro Care Center ( Site 2011) | Toyoake | Aichi |
| Japan | Kanagawa Psychiatric Center ( Site 2035) | Yokohama-Shi | Kanagawa |
| Korea, Republic of | Inje University Busan Paik Hospital ( Site 0604) | Busan | Pusan-Kwangyokshi |
| Korea, Republic of | Kyungpook National University Hospital ( Site 0601) | Daegu | Taegu-Kwangyokshi |
| Korea, Republic of | Seoul National University Hospital ( Site 0600) | Seoul | |
| Latvia | Daugavpils Psihoneirologiska Slimnica ( Site 8005) | Daugavpils | |
| Latvia | Piejuras Slimnica Psihiatriska Klinika ( Site 8001) | Liepaja | |
| Poland | Uniwersyteckie Centrum Kliniczne ( Site 0902) | Gdansk | Pomorskie |
| Poland | Specjal. Psychiatryczny ZOZ w Lodzi, Szpital im. Babinskiego ( Site 0905) | Lodz | Lodzkie |
| Poland | Centrum Medyczne HCP ( Site 0913) | Poznan | Wielkopolskie |
| Poland | Klinika Psychiatryczna Wydzialu Nauki o Zdrowiu WUM ( Site 0900) | Pruszkow | Mazowieckie |
| Poland | Samodzielny Wojewódzki Zespól Publicznych Zakladów Psychiatrycznej Opieki Zdrowotnej w Warszawie ( S | Warsaw | Mazowieckie |
| Romania | Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0815) | Bucharest | Bucuresti |
| Romania | Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0816) | Bucharest | Bucuresti |
| Romania | Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0817) | Bucharest | Bucuresti |
| Romania | Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0818) | Bucharest | Bucuresti |
| Romania | Institutul de Psihiatrie Socola ( Site 0810) | Ia?i | Iasi |
| Romania | Institutul de Psihiatrie Socola ( Site 0814) | Ia?i | Iasi |
| Russian Federation | Arkhangelsk Regional Psychiatric Clinical Hospital ( Site 6020) | Arkhangelsk | Arkhangel Skaya Oblast |
| Russian Federation | SGHI Leningrad Region Psyconeurology Dispensary ( Site 6017) | Leningrad Region | Leningradskaya Oblast |
| Russian Federation | Lipetsk Regional Psychoneurology Hospital ( Site 6021) | Lipetsk | Lipetskaya Oblast |
| Russian Federation | Central Moscow Regional Clinical Psychiatric Hospital ( Site 6018) | Moscow | Moskva |
| Russian Federation | Moscow Scientific Research Institute for Psychiatry ( Site 6013) | Moscow | Moskva |
| Russian Federation | Psychiatric Clinical Hospital 4 named after PB Gannushkin ( Site 6016) | Moscow | Moskva |
| Russian Federation | Psychiatric Clinical Hospital 4 named after PB Gannushkin-Psychiatric department 4 ( Site 6023) | Moscow | Moskva |
| Russian Federation | Bekhterev Research Institute for Psychoneurology ( Site 6008) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6000) | St. Petersburg | Sankt-Peterburg |
| Russian Federation | SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6001) | St. Petersburg | Sankt-Peterburg |
| Russian Federation | SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6002) | St. Petersburg | Sankt-Peterburg |
| Russian Federation | Stavropol Region Psychiatric Hospital #2 ( Site 6005) | Stavropol | Stavropol Skiy Kray |
| Russian Federation | Federal State Scientific Institution Research Institute of Mental Health ( Site 6014) | Tomsk | Tomskaya Oblast |
| Russian Federation | Yaroslavl Regional Clinical Psychiatry Hospital ( Site 6022) | Yaroslavl | Yaroslavskaya Oblast |
| Serbia | Clinical Center of Serbia ( Site 5101) | Belgrade | Beograd |
| Serbia | Clinical Center of Serbia ( Site 5107) | Belgrade | Beograd |
| Serbia | Institut za mentalno zdravlje ( Site 5105) | Belgrade | Beograd |
| Serbia | University Clinical Hospital Center "Dr. Dragisa Misovic - Dedinje" ( Site 5104) | Belgrade | Beograd |
| Serbia | Special Hospital for Psychiatric Diseases Kovin ( Site 5108) | Kovin | Vojvodina |
| Serbia | Special Hospital for Psychiatric Diseases Kovin ( Site 5109) | Kovin | Vojvodina |
| Serbia | Clinical Center Kragujevac ( Site 5100) | Kragujevac | Sumadijski Okrug |
| Serbia | Clinical Center Kragujevac ( Site 5102) | Kragujevac | Sumadijski Okrug |
| Serbia | Clinical Center Kragujevac ( Site 5106) | Kragujevac | Sumadijski Okrug |
| Taiwan | China Medical University Hospital ( Site 9006) | Taichung | |
| Taiwan | National Taiwan University Hospital ( Site 9001) | Taipei | |
| Taiwan | Taipei City Hospital, Songde Branch ( Site 9004) | Taipei | |
| Taiwan | Taipei Veterans General Hospital ( Site 9000) | Taipei | |
| Taiwan | Chang Gung Memorial Hospital - Linkou Branch ( Site 9002) | Taoyuan | |
| Ukraine | Dnepropetrovsk Regional Clinical Hospital Mechnikov-Regional Centre of Psychosomatic Disorders base | Dnipro | Dnipropetrovska Oblast |
| Ukraine | CNE "Precarpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council"" ( | Ivano-Frankivsk | Ivano-Frankivska Oblast |
| Ukraine | CNE of Kharkiv Reg. Council Reg. Clinical Psychiatric Hospital Nub 3 ( Site 7012) | Kharkiv | Kharkivska Oblast |
| Ukraine | Institute of Neurology,Psychiatry and Narcology AMS Ukraine ( Site 7011) | Kharkiv | Kharkivska Oblast |
| Ukraine | CNE. Kherson Regional Psychiatric Hospital ( Site 7004) | Kherson | Khersonska Oblast |
| Ukraine | CNE Clinical Hospital PSYCHIATRY of executive body of Kyiv City Council -Kyiv City State Admin ( Sit | Kyiv | Kyivska Oblast |
| Ukraine | Kyiv City Psychoneurological Hospital 2 ( Site 7008) | Kyiv | Kyivska Oblast |
| Ukraine | MNE of KRC-Regional psychiatric and narcological medical association ( Site 7005) | Kyiv | Kyivska Oblast |
| Ukraine | CNE Cherkasy reg. psychiatric hospital of Cherkasy regional council ( Site 7009) | Smila | Cherkaska Oblast |
| Ukraine | CNE "Vinnytsia Regional Clinical Psycho-neurological hospita-Mixed (men and women) department #2 ( S | Vinnytsya | Vinnytska Oblast |
| United States | Atlanta Center For Medical Research ( Site 1022) | Atlanta | Georgia |
| United States | Community Clinical Research ( Site 1057) | Austin | Texas |
| United States | CITRIALS ( Site 1010) | Bellflower | California |
| United States | Pillar Clinical Research ( Site 1047) | Bentonville | Arkansas |
| United States | Massachusetts General Hospital ( Site 1035) | Boston | Massachusetts |
| United States | New Hope Clinical Research ( Site 1050) | Charlotte | North Carolina |
| United States | Ascension Saint Elizabeth ( Site 1000) | Chicago | Illinois |
| United States | Pillar Clinical Research, LLC ( Site 1038) | Chicago | Illinois |
| United States | Uptown Research Institute ( Site 1052) | Chicago | Illinois |
| United States | ProScience Research Group ( Site 1046) | Culver City | California |
| United States | Midwest Clinical Research ( Site 1059) | Dayton | Ohio |
| United States | Midwest Clinical Research Center ( Site 1033) | Dayton | Ohio |
| United States | CenExel iResearch, LLC ( Site 1039) | Decatur | Georgia |
| United States | CBH Health ( Site 1044) | Gaithersburg | Maryland |
| United States | Collaborative Neuroscience Research, LLC ( Site 1041) | Garden Grove | California |
| United States | Behavioral Research Specialists, LLC ( Site 1032) | Glendale | California |
| United States | Behavioral Clinical Research ( Site 1058) | Hollywood | Florida |
| United States | Research Centers of America ( Hollywood )-Central Nervous System (CNS) ( Site 1065) | Hollywood | Florida |
| United States | Altea Research Institute ( Site 1012) | Las Vegas | Nevada |
| United States | Woodland International Research Group, LLC ( Site 1002) | Little Rock | Arkansas |
| United States | Hassman Research Institute Marlton Site ( Site 1040) | Marlton | New Jersey |
| United States | Premier Clinical Research Institute ( Site 1049) | Miami | Florida |
| United States | Behavioral Clinical Research , Inc ( Site 1013) | Miami Lakes | Florida |
| United States | Neuro-Behavioral Clinical Research ( Site 1055) | North Canton | Ohio |
| United States | Fort Lauderdale Behavioral Health Center ( Site 1028) | Oakland Park | Florida |
| United States | Pillar Clinical Research, LLC ( Site 1004) | Richardson | Texas |
| United States | CITRIALS ( Site 1016) | Riverside | California |
| United States | Woodland Research Northwest, LLC ( Site 1036) | Rogers | Arkansas |
| United States | Arch Clinical Trials ( Site 1048) | Saint Louis | Missouri |
| United States | Artemis Institute for Clinical Research ( Site 1019) | San Diego | California |
| United States | California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) ( Site 103 | San Diego | California |
| United States | Schuster Medical Research Institute ( Site 1023) | Sherman Oaks | California |
| United States | Benchmark Research ( Site 1054) | Shreveport | Louisiana |
| United States | Richmond Behavioral Associates ( Site 1064) | Staten Island | New York |
| United States | Health Synergy Clinical Research ( Site 1051) | Stuart | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Bulgaria, Croatia, Japan, Korea, Republic of, Latvia, Poland, Romania, Russian Federation, Serbia, Taiwan, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo | The PANSS assesses the severity of schizophrenia symptoms through a 30-item clinician-rated inventory organized into a positive subscale (7 items), a negative subscale (7 items) and a general psychopathology subscale (16 items). For each item, symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score for each participant will be calculated as the sum of the rating assigned to each of the 30 PANSS items and will range from 30 (lowest total score) to 210 (highest total score). Higher scores reflect more severe symptoms of schizophrenia. | Baseline, Week 6 | |
| Primary | Number of participants who experience one or more adverse events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. | ~Up to Week 14 | |
| Primary | Number of participants who discontinue study treatment due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. | ~Up to Week 12 | |
| Secondary | Change from baseline in PANSS positive subscale (PSS) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo | The PANSS Positive Subscale (PSS) assesses the severity of schizophrenia symptoms and the PANSS PSS score for each participant will be calculated as the sum of the rating assigned to each of the 7 PSS items and will range from 7 (lowest total score) to 49 (highest total score). Higher scores reflect more severe symptoms of schizophrenia. | Baseline, Week 6 | |
| Secondary | Change from baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo | The CGI-S is a single item 7-point clinician rated scale for assessing the global severity of the participant's illness. CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill). A decrease in the CGI-S score indicates reduced severity of the participant's illness. | Baseline, Week 6 | |
| Secondary | Change from baseline in weight at Week 12: MK-8189 24 mg, MK-8189 16 mg, or risperidone | Body weight will be measured using a standardized scale. | Baseline, Week 12 | |
| Secondary | Change from baseline in weight at Week 6: MK-8189 24 mg, MK-8189 16 mg, MK-8189 8 mg or placebo | Body weight will be measured using a standardized scale. | Baseline, Week 6 |
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